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Background <p>Neonatal hyperbilirubinemia is common, with significant elevations resulting in long-term neurological impairments or death, if untreated. Hospital-based analyzers are the gold standard for measuring total serum bilirubin (TSB), but are expensive, technically demanding, and often unavailable in lower resource settings. The purpose of this study was to compare TSB between the Bilistick System 2.0 point-of-care (Bilistick POC) and hospital-based analyzer (Hospital) under real-world conditions.</p> Methods <p>This prospective diagnostic study was conducted in a Southwest Ohio community-based healthcare system by 6 study investigators, across 4 test sites, and included 80 newborns (&lt;2 weeks old, 31–42 weeks’ gestation) scheduled for TSB testing. Newborn blood TSB was tested with Bilistick POC and Hospital analyzers, plus 25 bilirubin spiked adult samples to extend the TSB range.</p> Results <p>Bilistick POC and Hospital TSB showed high correlation (<i>R</i>² = 0.99, <i>p </i>&lt; 0.001) across devices, investigators, and locations. Bland–Altman analysis demonstrated minimal bias (mean ratio = 1.005) with 95% limits (0.8426–1.167), over TSB of 2.3–29.5 mg/dL. No significant inter-investigator variation was detected (<i>p</i> = 0.107) and hemolysis was minimal (7.5%).</p> Conclusion <p>These findings support Bilistick POC as an easily utilized, consistent, and portable testing device to measure TSB compared to a hospital-based analyzer.</p> Impact <p><UnorderedList Mark="Bullet"> <ItemContent> <p>Point-of-care testing for total serum bilirubin with the Bilistick 2.0 point-of-care system (Bilistick POC) is a more affordable, faster, reliable, consistent, easy-to-use, and more efficient method compared to expensive hospital laboratory equipment.</p> </ItemContent> <ItemContent> <p>Resource-limited settings may benefit from POC TSB testing where advanced laboratory infrastructure is limited.</p> </ItemContent> </UnorderedList></p> <p><UnorderedList Mark="Bullet"> <ItemContent> <p>The Bilistick POC testing device is comparable to hospital-based testing analyzers.</p> </ItemContent> </UnorderedList></p>

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Point-of-care serum bilirubin as an efficient and comparable alternative to hospital based testing

  • 期刊论文

  • 发表日期：

    2025年12月23日

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  • Jonathan D. Toot,
  • Michelle L. Pershing,
  • Aaron L. Berenson,
  • Stephen E. Grossi,
  • Shaunrick A. Stoll,
  • Loren A. Nallu,
  • Emmanuel J. Chiebuka,
  • Crystal D. Hill

摘要

Background

Neonatal hyperbilirubinemia is common, with significant elevations resulting in long-term neurological impairments or death, if untreated. Hospital-based analyzers are the gold standard for measuring total serum bilirubin (TSB), but are expensive, technically demanding, and often unavailable in lower resource settings. The purpose of this study was to compare TSB between the Bilistick System 2.0 point-of-care (Bilistick POC) and hospital-based analyzer (Hospital) under real-world conditions.

Methods

This prospective diagnostic study was conducted in a Southwest Ohio community-based healthcare system by 6 study investigators, across 4 test sites, and included 80 newborns (<2 weeks old, 31–42 weeks’ gestation) scheduled for TSB testing. Newborn blood TSB was tested with Bilistick POC and Hospital analyzers, plus 25 bilirubin spiked adult samples to extend the TSB range.

Results

Bilistick POC and Hospital TSB showed high correlation (R² = 0.99, p < 0.001) across devices, investigators, and locations. Bland–Altman analysis demonstrated minimal bias (mean ratio = 1.005) with 95% limits (0.8426–1.167), over TSB of 2.3–29.5 mg/dL. No significant inter-investigator variation was detected (p = 0.107) and hemolysis was minimal (7.5%).

Conclusion

These findings support Bilistick POC as an easily utilized, consistent, and portable testing device to measure TSB compared to a hospital-based analyzer.

Impact

Point-of-care testing for total serum bilirubin with the Bilistick 2.0 point-of-care system (Bilistick POC) is a more affordable, faster, reliable, consistent, easy-to-use, and more efficient method compared to expensive hospital laboratory equipment.

Resource-limited settings may benefit from POC TSB testing where advanced laboratory infrastructure is limited.

The Bilistick POC testing device is comparable to hospital-based testing analyzers.